Apparatus and methods for sealing a vascular puncture

ABSTRACT

An apparatus for sealing a puncture through tissue having an introducer sheath therein includes an elongate positioning member including a housing on a proximal end and an expandable member on a distal end, and a cartridge advanceable along the positioning member from a proximal position to a distal position. The cartridge includes a tubular member including a sealant and an advancer member disposed within lumen of the tubular member. A sleeve is slidably disposed over the tubular member distal end such that, when the tubular member is advanced over the positioning member, the tubular member distal end enters the introducer sheath while the sleeve is stopped and slides over the tubular member to expose the tubular member distal end within the introducer sheath. The introducer sheath and cartridge are then withdrawn, exposing the sealant within the puncture.

FIELD OF THE INVENTION

The present invention relates generally to apparatus and methods forsealing punctures in a body, and more particularly, to apparatus andmethods for sealing a vascular puncture extending through tissue into ablood vessel, and to apparatus and methods for delivering a plug,sealant, and/or other material into a percutaneous puncture extendingfrom a patient's skin to a blood vessel or other body lumen, e.g., toseal the puncture.

BACKGROUND

Apparatus and methods are known for accessing a patient's vasculaturepercutaneously, e.g., to perform a procedure within the vasculature, andfor sealing the puncture that results after completing the procedure.For example, a hollow needle may be inserted through a patient's skinand overlying tissue into a blood vessel. A guide wire may be passedthrough the needle lumen into the blood vessel, whereupon the needle maybe removed. An introducer sheath may then be advanced over the guidewire into the vessel, e.g., in conjunction with or subsequent to one ormore dilators.

A catheter or other device may be advanced through the introducer sheathand over the guide wire into a position for performing a medicalprocedure. Thus, the introducer sheath may facilitate accessing and/orintroducing various devices into the vessel, while minimizing trauma tothe vessel wall and/or minimizing blood loss. Upon completing theprocedure, the device(s) and introducer sheath may be removed, leaving apuncture extending between the skin and the vessel wall.

To seal the puncture, external pressure may be applied to the overlyingtissue, e.g., manually and/or using sandbags, until hemostasis occurs.This procedure, however, may be time consuming and expensive, requiringas much as an hour of a medical professional's time. It is alsouncomfortable for the patient, and may require the patient to remainimmobilized in the operating room, catheter lab, or holding area. Inaddition, a risk of hematoma exists from bleeding before hemostasisoccurs.

Various apparatus and methods have been suggested for sealing apercutaneous puncture instead of using external pressure. For example,U.S. Pat. No. 5,108,421 to Fowler discloses a plug that may be deliveredinto a puncture through tissue. U.S. Pat. Nos. 5,192,302 and 5,222,974issued to Kensey et al. describe a bioabsorbable collagen plug that maybe delivered through an introducer sheath into a puncture site. Thedisclosed plug, however, may be difficult to position properly withrespect to the vessel, which may be significant since it is generallyundesirable to expose the collagen material within the bloodstream whereit may float downstream and cause an embolism.

U.S. Pat. No. 6,605,294 describes rods, plugs, and crushed orirregularly shaped pieces of substantially dehydrated hydrogel that maybe introduced into a lumen or void in a patient's body, e.g., to seal orplug a biopsy needle track, reinforce weak tissue, or deliver atherapeutic compound. In one embodiment, a plug of dehydrated hydrogelmay be deployed into the site of an arteriotomy and allowed to hydratein the presence of the tissue fluids and blood, to fill the tract of thecatheter sheath and prevent further bleeding. By swelling to equilibriumhydration, the plug may lock itself firmly in place and thus reduce therisk of formation of a large hemotoma at the site of the puncture.

U.S. Pat. No. 6,703,047 discloses dehydrated hydrogel precursor-based,tissue adherent compositions. The hydrogels may be used, for example,for sealing fluid leaks from tissue, as adherent drug delivery depots,and as means for augmenting and/or supporting tissue. The hydrogels maybe administered directly to an open wound site or may be dispensed,e.g., using a non-adhesive backing material, an absorbable backingmaterial, a syringe applicator, a powder atomization or aerosolizationsystem, or a needle-less injector.

SUMMARY OF THE INVENTION

The present invention is directed to apparatus and methods for sealing apuncture in a body, and, more particularly, to apparatus and methods forproviding temporary or permanent hemostasis within a vascular punctureextending into a blood vessel, and/or to apparatus and methods fordelivering a sealant and/or other material into a percutaneous punctureextending from a patient's skin to a blood vessel or other body lumen.

In accordance with one embodiment, an apparatus is provided for sealinga puncture extending through tissue having an introducer sheath thereinthat includes a proximal end including a hub, a distal end, and a lumenextending therebetween. The apparatus includes an elongate positioningmember including a housing on a proximal end thereof, and an expandablepositioning element on a distal end thereof, and a cartridge advanceablealong the positioning member from a proximal position adjacent thehousing to a distal position. The cartridge may include a tubularmember, a sealant disposed within a lumen of the tubular member, e.g.,adjacent the tubular member distal end, and an advancer member disposedwithin the tubular member lumen adjacent the sealant, e.g., for exposingthe sealant from the tubular member lumen when the tubular member isretracted proximally relative to the advancer member.

In addition, the cartridge includes a sleeve slidably disposed over thetubular member distal end, e.g., covering a slitted distal tip of thetubular member. Optionally, the sleeve may include an inner surfaceconfigured to provide preferential or different frictional interferencewith an outer surface of the tubular member, e.g., to allow proximalmovement and resist distal movement of the sleeve over the tubularmember. At least a portion of the sleeve may be sized to abut theintroducer sheath hub such that, when the tubular member is advancedfrom the proximal position to the distal position, the tubular memberdistal end enters the introducer sheath lumen while the sleeve isstopped by the introducer sheath hub and slides over the tubular memberto expose the tubular member distal end within the introducer sheathlumen.

For example, in one embodiment, the sleeve may include a distal portionsized to enter the introducer sheath hub when the cartridge is advancedtowards the distal position and a proximal portion that abuts theintroducer sheath hub to prevent the entire sleeve from entering theintroducer sheath lumen. The introducer sheath hub may include a valvetherein, and the sleeve distal portion may at least partially open thevalve when the cartridge is advanced towards the distal position, e.g.,to facilitate the tubular member distal end entering the introducersheath lumen.

Optionally, the positioning member and/or cartridge may include one ormore features that limit distal movement of the tubular member when thecartridge is advanced from the proximal position to the distal position.For example, features may be provided on the positioning member toprevent further distal movement of the tubular member when the tubularmember distal end is spaced a predetermined distance from thepositioning element.

In accordance with another embodiment, a system is provided for sealinga puncture through tissue that generally includes an introducer sheath,a positioning member, and a cartridge. The introducer sheath may includea proximal end including a hub, a distal end sized for introduction intoa puncture, and a lumen extending therebetween. The positioning membermay include an elongate member including a housing on a proximal endthereof and an expandable positioning element on a distal end thereof.The cartridge may be advanceable along the positioning member from aproximal position to a distal position, and may include a tubular memberincluding a sealant and an advancer member disposed within lumen of thetubular member. A sleeve is slidably disposed over the tubular memberdistal end such that, when the tubular member is advanced over thepositioning member after introducing the positioning element through theintroducer sheath, the tubular member distal end enters the introducersheath lumen while the sleeve is stopped by the introducer sheath huband slides over the tubular member to expose the tubular member distalend within the introducer sheath lumen.

In accordance with still another embodiment, a method is provided forsealing a puncture extending through tissue to a body lumen, thepuncture having an introducer sheath therein. An apparatus may beprovided including an elongate positioning member including proximal anddistal ends, a cartridge slidable on the positioning member and carryinga sealant therein, and a slidable sleeve located over a distal end ofthe cartridge.

The distal end of the positioning member may be introduced through alumen of the introducer sheath until a positioning element thereon isdisposed within the body lumen. Optionally, the positioning element maybe expanded within the body lumen, and the positioning member may beretracted until the expanded positioning element contacts a wall of thebody lumen.

The cartridge may be advanced over the positioning member, e.g., untilthe sleeve on the cartridge contacts a proximal end of the introducersheath. The cartridge may be advanced. further, e.g., as onesubstantially continuous movement, such that the cartridge distal endenters the introducer sheath lumen while the sleeve is stopped by theintroducer sheath. During this further advancement, the sleeve may slideover the cartridge to expose the cartridge distal end within theintroducer sheath lumen, e.g., until a distal position is attained.

The introducer sheath and cartridge may then be at least partiallyretracted from the puncture, thereby exposing the sealant within thepuncture distally beyond the introducer sheath. The expanded positioningelement may then be collapsed, and the positioning member withdrawn fromthe puncture, e.g., leaving the sealant within the puncture. In oneembodiment, the cartridge may include an advancer member adjacent thesealant that remains within the puncture when the introducer sheath andcartridge are retracted. In this embodiment, the positioning member maybe withdrawn through the sealant and advancer member. For example, theadvancer member may be held substantially stationary while thepositioning member is withdrawn from the puncture to prevent substantialproximal movement of the sealant. In addition or alternatively, theadvancer member may be advanced to compress the sealant within thepuncture, e.g., before or after withdrawing the positioning member. Theadvancer member may then be withdrawn, leaving the sealant within thepuncture.

Other aspects and features of the present invention will become apparentfrom consideration of the following description taken in conjunctionwith the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

It will be appreciated that the exemplary apparatus shown in thedrawings are not necessarily drawn to scale, with emphasis instead beingplaced on illustrating the various aspects and features of theillustrated embodiments.

FIGS. 1A and 1B are side and perspective views, respectively, of anexemplary embodiment of an apparatus for delivering a sealant into apuncture through tissue, including a positioning member, and a cartridgemovable over the positioning member that includes the sealant and aslidable sleeve.

FIG. 2A is a partial cross-section of the apparatus of FIGS. 1A and 1Bbefore the slidable sleeve is directed over a distal end of thecartridge.

FIG. 2B is a cross-sectional detail of the sleeve of FIG. 2A.

FIGS. 3A and 3B are side views of the apparatus of FIGS. 1A and 1B withthe positioning member inserted into an introducer sheath, showing thecartridge in proximal and distal positions, proximally.

FIGS. 4A and 4B are cross-sectional views of a housing on the cartridgeof the apparatus of FIGS. 3A and 3B, with the cartridge in proximal anddistal positions, respectively.

FIGS. 5A-5D are cross-sectional views of a patient's body, showing amethod for sealing a puncture extending from a patient's skin to a bloodvessel using the apparatus of FIGS. 1A and 1B.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

Turning to the drawings, FIGS. 1A and 1B show an exemplary embodiment ofan apparatus 10 for sealing a puncture through tissue. Generally, theapparatus 110 includes a positioning member 14 and a cartridge 16carried on the positioning member 14 for delivering sealant 2 thereininto a puncture (not shown). As shown in FIGS. 3A and 3B, the apparatus10 may be part of a system, e.g., which may also include a delivery,access, procedure, introducer, or other sheath 80. Optionally, theapparatus 10 and/or system may include one or more other components,e.g., a needle, guidewire, and/or other instrument for creating apuncture (not shown), and/or a source of additional sealing compound(also not shown).

As best seen in FIG. 2A, the cartridge 16 includes an elongate tubularmember 20 carrying the sealant 2 therein, an advancer member 30 adjacentthe sealant 2, and a slidable sleeve or cover 50, as described furtherbelow. Generally, the tubular member 20 includes a proximal end 22, adistal end 24 sized for introduction into an introducer sheath and/orpuncture (not shown), and a lumen 26 extending between the proximal anddistal ends 22, 24. The tubular member 20 may be substantially rigid,semi-rigid, or flexible, e.g., such that the tubular member 20 may beadvanced through an introducer sheath or otherwise into a puncturethrough tissue. A handle or hub 23 may be provided on the proximal end22, e.g., for releasably coupling the cartridge 16 to the positioningmember 14, as best seen in FIGS. 4A and 4B and described further below.

As shown in FIG. 2A, a distal tip 25 of the tubular member 20 may besplit, e.g., including one or more slits or other features 27, e.g., tofacilitate exposing the sealant 2 from the cartridge 16. For example, asplit distal tip 25 may facilitate retraction of the tubular member 20relative to the sealant 2, e.g., by providing extra flexibility at thedistal end 24 and/or allowing the distal end 24 to expand or otherwiseopen slightly. This may allow the distal end 24 to separate more easilyfrom the sealant 2, e.g., as the sealant begins to expand upon beingexposed to an aqueous environment, which may reduce the risk of thesealant 2 binding up within or otherwise resisting exposure from thelumen 26 of the tubular member 20.

In addition, the slits 27 may accommodate slight expansion of thesealant 2 before being exposed from the tubular member 20. For example,a distal surface of the sealant 2 may be exposed to bodily fluids whenthe cartridge 16 is advanced into a puncture, which may hydrate andcause the distal end of the sealant 2 to expand slightly. Optionally,the distal end 24 of the tabular member 20 may be exposed to water orother fluid before use of the apparatus 10, e.g., to partially hydratethe distal end of the sealant 2 and cause the distal end to expandslightly. The slits 27 may allow the distal end 24 of the tubular member20 to open to accommodate such expansion. Otherwise, if the sealant 2hydrates and/or otherwise expands within the tubular member 20, thesealant 2 may impose radially outward forces, which may hinderretracting the tubular member 20 to expose the sealant 2.

In the exemplary embodiment shown, a single longitudinal slit 27 is cutor otherwise formed on one side of the distal tip 25 that extendsproximally from the distal tip 25, e.g., about ten to twenty millimeters(10-20 mm). Alternatively, a pair of slits may be provided, e.g., onopposite sides of the distal tip 25 or more than two slits may beprovided, if desired (not shown) The length of the slit(s) may be lessthan, substantially equal to, or longer than the length of the sealant2, e.g., to reduce the risk of jamming if the sealant 2 begins to expandwithin the distal tip as described elsewhere herein.

A slit that is longer than the sealant 2 may provide hydraulic benefits,e.g., when the cartridge 16 is advanced to introduce the sealant 2 intoa puncture. For example, during use, as the cartridge 16 is advancedinto an introducer sheath (not shown), as described further below, fluidinside the introducer sheath may be displaced distally by the cartridge16, which may increase pressure at the distal end 24 of the tubularmember 20 and/or introducer sheath. This increased hydraulic pressure atthe distal end 24 of the tubular member 20 may also transmit along thesides of the cartridge 16, e.g., if there is a gap between the innerdiameter of the introducer sheath and the outer diameter of the tubularmember 20. A longer slit 27 may allow some relief of this pressure,e.g., by blood or other fluid within the introducer sheath flowing indirectly behind the sealant 2 within the lumen 26 of the tubular member20 and/or otherwise within the cartridge 16. Such infusion behind thesealant 2 may also have the benefit of pre-hydrating the sealant 2,which may enhance the ability of the sealant 2 to expand quickly whendeployed within a puncture or otherwise within the patient's body.

With further reference to FIG. 2A, the advancer member 30 may be anelongate tubular body, e.g., a plunger or catheter, including a proximalend 32, a distal end 34 sized for introduction into the lumen 26 of thetubular member 20, and a lumen 36 extending between the proximal anddistal ends 32, 34. The advancer member 30 may be sized for beingstidably received within the lumen 26 of the tubular member 20, althoughthe advancer member 30 may abut or otherwise interact with the hub 23 ofthe cartridge 16, e.g., such that the advancer member 30 is advanceddistally when the cartridge 16 is advanced. The distal end 34 of theadvancer member 30 may terminate in a substantially blunt distal tip,e.g., to facilitate contacting, pushing, and/or maintaining the sealant2 within a puncture, as described further. below.

The advancer member 30 may be substantially rigid, semi-rigid, and/orsubstantially flexible, having sufficient column strength to allowproximal movement of the tubular member 20 relative to the sealant 2without buckling the advancer member 30 and/or to allow the distal end34 of the advancer member 30 to be advanced to compress the sealant 2within a puncture, e.g., by pushing from the proximal end 32, asdescribed further below. The advancer member 30 may also include a lumen36 extending between the proximal and distal ends 32, 34, e.g., toaccommodate the positioning member 14, a guidewire, a flowable sealingcompound, and/or fluid (not shown).

Optionally, the advancer member 30 may include one or more elements (notshown) on the proximal end 32, e.g., for interacting with one or morecooperating elements (also not shown) on the positioning member 14,e.g., to limit movement of the advancer member 30 relative to thepositioning member 14. For example, the element(s) may simply be arelatively narrow region (not shown) on the proximal end 32.Alternatively, the element(s) may be a separate collar or sleeve, one ormore inwardly oriented detents, and the like (also not shown) attachedto or otherwise formed on the proximal end 32 of the advancer member 30.

The sealant 2 may be disposed within the lumen 26 of the tubular member20 proximate to the distal end 24, e.g., immediately adjacent the distaltip 25, as shown in FIG. 2A. The lumen 26 may be sized such that thetubular member 20 and sealant 2 are slidable relative to one another,e.g., to allow the tubular member 20 to be retracted proximally relativeto the sealant 2 and/or advancer member 30, as described further below.

The sealant 2 may include a biocompatible, bioabsorbable, and/orexpandable material, such as a freeze-dried hydrogel. The sealant 2 mayhave a solid or hollow cylindrical shape, a rolled sheet shape, a diskshape, or other shapes or cross-sections, such as elliptical,triangular, square, conical, disk, polygonic shapes. For example, thesealant 2 may be formed from a solid material including a lumen (notshown) extending between proximal and distal ends thereof. The lumen maybe created by rolling a sheet of material around a mandrel, by molding,by boring into or otherwise removing material from an already formedsolid material, and the like. The lumen may be dimensioned such that thepositioning member 14, a guidewire or other instrument (not shown) mayslide or otherwise pass through the sealant 2, as described elsewhereherein.

In one embodiment, the sealant 2 may be formed from a biocompatibleand/or bioabsorbable hydrogel, e.g., polyethylene glycol (“PEG”), orother synthetic material. For example, the hydrogel may include alyophilized (i.e., freeze-dried) PEG polymer that includeshydrolytically degradable chemical groups, e.g., including a macroporouspolymer network, which may uptake fluid and expand when exposed to anaqueous environment. The magnitude of expansion or swelling (pre to posthydration) may be significant, e.g., between about two and ten times(2×-10×) its lyophilized size based on volume.

In addition or alternatively, the sealant 2 may include pro-thromboticmaterial, e.g., including one or more biological pro-thrombotics, suchas collagen, fibrin, carboxymethylcellulose, oxidized cellulose,alginates, gelatin, or other protein-based material, and/or syntheticmaterials, such as polyglycolic acids (PGA's), polyactides (PLA's),polyvinyl alcohol, and the like.

Optionally, the sealant 2 may include one or more therapeutic and/orpharmaceutical agents, e.g., to promote healing, prevent infectionand/or other adverse medical events, and the like. Such agents may beembedded in the sealant material and/or applied as one or more coatingsor layers. In addition or alternatively, the sealant 2 may besubstantially homogeneous, or may include one or more differentmaterials at one or more locations. For example, in one embodiment, thesealant 2 may include a carrier or core having first and second hydrogelprecursors disposed thereon in an unreactive state, which may provide anadherent coating when the sealant 2 is exposed to an aqueousenvironment.

Exemplary materials and methods for making and using them are disclosedin U.S. Pat. Nos. 6,152,943, 6,165,201, 6,179,862, 6,514,534, 6,379,373,6,703,047, 7,790,192, and in co-pending applications Ser. Nos.10/010,715 filed Nov. 9, 2001, 10/068,807 filed Feb. 5, 2002,10/454,362, filed Jun. 4, 2003, published as US 2004/0249342,10/982,384, filed Nov. 5, 2004, published as US 2006/0099238, and11/465,791, filed Aug. 18, 2006. The disclosures of these references areexpressly incorporated by reference herein.

Additionally, as shown in FIGS. 1A and 1B, the cartridge 16 includes asleeve or cover 50 slidably disposed over the tubular member 20, e.g.,for covering the distal end 24 before use and/or advancement of thecartridge 16. For example, the sleeve 50 may support the distal end 24,e.g., by covering the distal tip 25 and preventing premature expansionor separation of the slits 27, e.g., before the distal end 24 is exposedfrom the sleeve 50, as described further below.

As best seen in FIGS. 2A and 2B, the sleeve 50 may include a relativelylarge diameter proximal portion 52, e.g., sized to abut or otherwisecontact a hub or proximal end of an introducer sheath (not shown), and arelatively small diameter distal portion 54, e.g., sized to enter thehub and/or lumen of the introducer sheath (not shown). For example, theintroducer sheath hub may include one or more valves, e.g., a hemostaticvalve therein, and the sleeve distal portion 54 may be sized to enterthe hub and at least partially open the valve when the cartridge 16 isadvanced, e.g., to facilitate the distal end 24 of the tubular member 20entering the introducer sheath lumen, as described further below.

The sleeve 50 may have a relatively short length compared to the tubularmember 20, e.g., such that the sleeve 50 may slide proximally over thetubular member 20 a desired distance. For example, the sleeve 50 mayhave an overall length between about twelve and twenty four millimeters(12-24 mm), and the distal portion 54 may have a length, e.g., betweenabout three and twenty millimeters (3-20 mm).

Optionally, the sleeve 50 may include an inner lumen 56 configured toprovide preferential and/or different frictional interference with anouter surface of the tubular member 20. For example, the inner lumen 56may allow the sleeve 50 to slide freely proximally relative to thetubular member 20, while providing enhanced friction that resists distalmovement of the sleeve 50 over the tubular member 20. In addition oralternatively, the sleeve 50 may be releasably attached to the cartridge16, e.g., using a low bond adhesive, and the like, which may be releasedor otherwise overcome when the cartridge 16 is advanced into anintroducer sheath, as described further below.

In an exemplary embodiment, shown in FIG. 2B, the sleeve 50 may beformed from an outer annular body 53 defining the proximal portion 52,and a section of tubing 55 at least partially received within theannular portion 53, e.g., defining the distal portion 54. The componentsof the sleeve 50 may be made from the same or different materials, e.g.,plastic, metal, or composite materials. For example, the tubing 55 maybe formed from substantially rigid plastic, such as polyimide, and theannular body 53 may be formed from polyether block amide (PEBAX),polyurethane, silicone, or other relatively soft durometer materials.The components may be attached to one another, e.g., by bonding withadhesive, ultrasonic welding, fusing, melting, and the like.

As best seen in FIG. 2B, an annular portion 53 a of the annular body 53and the tubing 55 together define the lumen 56 that extends through thesleeve 50. The lumen 56 may be sized to allow the sleeve 50 to slideover the tubular member 20 (not shown, see, e.g., FIGS. 1A-2A), e.g.,while providing slight interference. For example, the annular portion 53a adjacent the tubing 55 may have an inner diameter slightly smallerthan the inner diameter 55 a of the tubing 55, such that, when thesleeve 50 is directed proximally over the tubular member 20 (e.g., whenthe tubular member 20 is advanced distally relative to the sleeve 50),the soft durometer material of the annular portion 53 a may bunch upslightly, thereby expanding the size of the lumen 56 and reducingfrictional interference between the sleeve 50 and the tubular member 20.Conversely, if the sleeve 50 is directed distally over the tubularmember 20 (or the tubular member 20 is directed proximally relative tothe sleeve 50), the annular portion 53 a surrounding the lumen 56 maystretch slightly, thereby reducing the size of the lumen 56 within theannular portion 53 a and increasing frictional interference between theannular portion 53 a of the sleeve 50 and the tubular member 20. In thismanner, the sleeve 50 may slide freely proximally while beingsubstantially prevented from sliding distally over the tubular member20.

Returning to FIGS. 1A and 1B, the positioning member 14 generallyincludes an elongate member 40 including a proximal end 42 (not shown,see, e.g., FIG. 3B), a distal end 44, and an occlusion or positioningelement 46 on the distal end 44. The positioning element 46 may be anexpandable member, such as a balloon, a wire mesh structure, anexpandable frame, an the like. The positioning element 46 may beselectively expandable, e.g., using a source of inflation media, a pullwire, and/or other actuator (not show , operable from the proximal end42 of the positioning member 14.

For example, as shown, the positioning element may be a balloon 46, andthe positioning member 14 may include a tubular body 40 including alumen (not shown) extending between the proximal and distal ends 42, 44and communicating with an interior of the balloon 46. In thisembodiment, the positioning member 14 may include a source of inflationmedia, e.g., a syringe (not shown), that may be coupled to a housing 48on the proximal end 142 of the positioning member 14. Optionally, thepositioning member 14 may include an internal pull wire (not show) thatcauses the balloon 46 to shorten during expansion and extend duringcollapse. Exemplary embodiments of positioning members 14 includingballoons that may be used are disclosed in co-pending applications Ser.No. 10/454,362, filed Jun. 4, 2003, published as US 2004/0249342, Ser.No. 11/112,877, filed Apr. 22, 2005, published as US 2006/0253072, andSer. No. 11/112/971, filed Apr. 22, 2005, and published internationalapplication WO 2006/115904. The entire disclosures of these referencesare expressly incorporated by reference herein.

Alternatively, the positioning element may be biased to an enlargedcondition, but may be compressed to a contracted condition, e.g., by anoverlying sleeve or other constraint (not shown). The constraint may beremoved to expose the positioning element, allowing the expandableelement to automatically expand to the enlarged condition. Additionalinformation on expandable structures that may be provided on thepositioning member 14 may be found in U.S. Pat. Nos. 6,238,412,6,635,068, and 6,890.343, and in co-pending application Ser. No.10/975,205, filed Oct. 27, 2004. The entire disclosures of thesereferences are expressly incorporated herein by reference.

Turning to FIGS. 5A-5B, the apparatus 10 may be used to position anddeliver the sealant 2 within a puncture, e.g., extra-vascularly justabove or otherwise adjacent to an arteriotomy in a blood vessel or otherbody lumen communicating with a puncture, as described further elsewhereherein. In one embodiment, as shown in FIG. 3A, the cartridge 16 (alongwith the advancer member 30 and sealant 2 within the tubular member 20)may be initially provided on the proximal end 42 of the positioningmember 14. For example, the housing 48 on the positioning member 14 andthe hub 23 on the cartridge 16 may be initially connected to oneanother, e.g., using one or more releasable detents 23 a, 48 a, as shownin FIG. 4A.

As shown in FIG. 3B, the cartridge 16 may be slidable distally along thepositioning member 14, e.g., by disconnecting the hub 23 from thehousing 48, and then advancing the cartridge 16, e.g., until the distalend 24 of the tubular member 20 is disposed adjacent the positioningelement 46. For example, the detents 23 a, 48 a may simply separate fromone another when the hub 23 is advanced away from the housing 48 withsufficient force. Alternatively, one of the hub 23 and housing 48 mayinclude an actuator or lock that may be activated (not shown) toseparate the detents 23 a, 48 a and/or otherwise allow the cartridge 16to be advanced relative to the positioning member 14.

Optionally, the cartridge 16 and/or positioning member 14 may includecooperating features that limit distal movement of the cartridge 16relative to the positioning member 14. For example, as shown in FIG. 4B,the hub 23 of the cartridge 16 may include a pocket 23 b and thepositioning member 14 may include a detent or other feature 41 a thatmay be received within the pocket 23 b when the cartridge 16 is advancedto a distal position. Optionally, the handle 23 of the cartridge 16 mayinclude a window or other opening (not shown) through which the pocket23 b may be seen, e.g., to allow a user to visually confirm when thedetent 41 has been fully received in the pocket 23 b.

The detent 41 a may be provided on the outer surface of the elongatemember 40 at a predetermined location between the proximal and distalends 42, 44 such that the distal end 24 of the tubular member 20 isspaced apart from the positioning element 46 by a predetermineddistance, e.g., providing between about two and five millimeters (2-5mm) clearance between the distal end 24 and the positioning element 46.Alternatively, the detent 41 a may be provided at a predeterminedlocation such that the distal end 24 of the tubular member may be jammedor otherwise extend t the positioning element 46, e.g., by zero to twomillimeters (0-2 mm).

The detent 41 a may be a raised feature formed or attached to theelongate member 40 at the predetermined location. For example, thedetent may be a proximal end of a section of tubing, e.g., heat shrinktubing, a collar, or other sleeve (not shown) attached around theelongate member 40, e.g., by bonding with adhesive, heat shrinking,ultrasonic welding, fusing, crimping, and the like. Alternatively, asshown, the detent 41 a may overmolded or otherwise formed directly onthe elongate member 40, as desired.

In addition or alternatively, the positioning member 14 and/or advancermember 30 may include one or more elements that engage when thecartridge 16 reaches a predetermined location when advanced along thepositioning member 14, e.g., to limit subsequent proximal movement ofthe advancer member 30 relative to the positioning member 14 when thetubular member 20 is subsequently retracted. For example, thepositioning member 14 may include a reduced diameter region (not shown)at a predetermined location, e.g., by providing a larger tube around asmaller inner tube or by machining, etching, or otherwise removing aportion of the tubular body of the positioning member 14 distal to thereduced region. The larger tube may extend from the proximal end of thepositioning member 14 to the desired location for the detent, or maysimply be a relatively short sleeve or other member (not shown) attachedaround or to the positioning member 14 at the desired location, e.g., toprovide a first ratchet or detent that the advancer member 30 may passover freely in the distal direction but not subsequently moveproximally.

The advancer member 30 may include a living hinge, tab, or other element37 (also not shown) on the proximal end 32 that may pass freely over thereduced regions, ratchets, and/or other detents on the positioningmember 14, yet may be unable to pass proximally back over the reducedregion. For example, as shown in FIG. 4B, the positioning member 14 mayinclude a ring, tab, or other raised element, e.g., a first and a secondraised element other detent 41 a, 41 b, and the advancer member 30 mayinclude a corresponding element (also not shown) that may allow distaladvancement but prevent proximal retraction once the advancer member 30is advanced a predetermined distance.

The first detent 41 a may be provided at a predetermined location on thepositioning member 14, e.g., a predetermined distance from thepositioning element 46 that substantially corresponds to a length of theadvancer member 30. As the cartridge 16 (and consequently the advancermember 30) is advanced over the positioning member 14, e.g., until thesealant 2 is disposed adjacent the positioning element 46, the element37 on the advancer member 30 may pass freely over the first detent 41 a,as best seen in FIG. 4B. Thereafter, the element 37 may prevent theadvancer member 30 from being retracted again past the first detent 41a, e.g., due to a blunt edge of the element 37 abutting the abruptdistal edge of the first detent 41 a. Thus, when the tubular member 20is retracted after the advancer member 30 has passed entirely over thefirst detent 41 a, the element 37 may prevent the advancer member 30from retracting with the tubular member 20. Optionally, as shown in FIG.4B, a second ratchet or detent 41 b (shown in phantom) may be providedon the positioning member 14 distal to the first detent 41 a, e.g., overwhich the advancer member 30 may be advanced further, e.g., duringcompression of the sealant 2 after deployment, as described furtherbelow. The second detent 41 b may be another tube or other feature (notshown) attached to or formed on the positioning member 14, e.g., thatprovides a blunt distal edge.

In addition or alternatively, one or more markers may be provided on theapparatus 10, e.g., to identify when components are located at one ormore desired positions or otherwise to facilitate use of the apparatus10. For example, as shown in FIG. 5A, the positioning member 14 mayinclude one or more markers at predetermined locations on the elongatemember 40. Such markers may provide visual confirmation when thecartridge 16 has been advanced to a desired distal position, e.g., whenthe marker(s) 43 emerge from the hub 23 as the cartridge 16 is advancedover the positioning member 14.

In addition or alternatively, as shown in FIG. 5D, the advancer member30 may include one or more markers 33 thereon, which may be visible whenthe cartridge 16 is advanced to a distal position and the tubular member20 is retracted to expose the sealant 2. These markers 33 may alsoprovide visual guides to inform the user when the advancer member 30 ismanipulated, e.g., advanced into a puncture to compress the sealant 2therein, as described further below.

As best seen in FIGS. 3A, 3B, and 5A-5D, the apparatus 10 is generallyused in cooperation with an introducer sheath 80. The introducer sheath80 may part of a system or kit including the apparatus 10 or may be anindependent device. Generally, the introducer sheath 80 includes aproximal end 82, a distal end 84 sized for insertion into a puncture 90through tissue, and a lumen 86 extending between the proximal and distalends 82, 84. The introducer sheath 80 may be formed from a substantiallyrigid, semi-rigid, and/or flexible tubular body including a hub 83 onthe proximal end 82. The introducer sheath 80 may have sufficient lengthto extend from a patient's skin through any intervening tissue into ablood vessel or other body lumen, e.g., having a length between aboutten centimeters and twenty centimeters (10-20 cm), and may have an outerdiameter between about 1.6 millimeters and five millimeters (1.6-5 mm).The distal end 84 may be tapered and/or may include a substantiallyatraumatic distal tip 85 for facilitating advancement through apuncture.

The introducer sheath 80 may be formed using known materials and/ormethods, e.g., plastic with the tubular body and hub 83 substantiallypermanently connected together, e.g., using an interference fit, one ormore mating connectors (not shown), bonding with adhesive, ultrasonicwelding, and the like. The hub 83 generally includes one or more seals,e.g., one or more hemostatic seals (not shown) therein, which mayprevent flow of blood or other fluids out of the hub 83 from the lumen86, yet accommodate insertion of one or more instruments into the lumen26, such as the positioning member 14 and/or cartridge 16. Optic asshown, the hub 83 may include a side port 89 communicating with thelumen 86, e.g., for coupling a source of saline or other fluid (notshown) to the hub 83.

Turning to FIGS. 5A-5D, an exemplary method is shown for sealing apuncture 90, e.g., using the apparatus 10 to deliver a sealant 2, e.g.,to achieve hemostasis within the puncture 90. Generally, the puncture 90extends from a patient's skin 92 through intervening tissue 96, e.g., toa body lumen 94. In an exemplary embodiment, the puncture 90 may be apercutaneous puncture communicating with a blood vessel 94, such as afemoral artery, carotid artery, and the like.

In an exemplary method, the puncture 90 may be created using knownprocedures, e.g., using a needle, guidewire, one or more dilators, andthe like (not shown). An introducer sheath 80 may be advanced throughthe puncture 90 into the vessel 94, e.g., over a guide wire placedthrough the puncture 90 into the vessel 94. The introducer sheath 80 mayprovide access into the vessel 92 for one or more instruments (notshown), e.g., to allow one or more diagnostic and/or interventionalprocedures to be performed via the vessel 94. Upon completing theprocedure(s) via the vessel 94, any such instrument(s) may be removedfrom the puncture 90, leaving the introducer sheath 80 extending throughthe puncture 90 into the vessel 94.

With reference to FIG. 5A, the positioning member 14 may be introducedinto and/or through the lumen 46 of the introducer sheath 80, e.g., withthe expandable positioning element 46 in a collapsed condition. Thecartridge 16, along with the sealant 2 and advancer member 30, may beprovided initially on the proximal end 42 of the positioning member 40,e.g., as shown in FIG. 3A. Thus, the distal end 24 of the tubular member20 may initially be located outside the puncture 90 when the positioningmember 40 is advanced into the puncture 90.

Still referring to FIG. 5A, the distal end 44 of the positioning member140 may be inserted through the puncture 90 (via the introducer sheath80) and into the vessel 94. Once the positioning element 46 is disposedwithin the vessel 94, i.e., beyond the distal end 84 of the introducersheath 80, the positioning element 46 may be expanded to an enlargedcondition, as shown. After expanding the positioning element 46, thepositioning member 40 may be at least partially withdrawn until thepositioning element 46 contacts the wall of the vessel 94, e.g., tosubstantially seal the vessel 94 from the puncture 90.

In an exemplary method, this may involve a two-step process (although itmay be completed in a single substantially continuous action). First,with the positioning element 46 expanded within the vessel 94, thepositioning member 14 may be withdrawn until the positioning element 46contacts the distal end 84 of the introducer sheath 80, which mayprovide a first tactile feedback to the user (i.e., that the positioningelement 46 has contacted the introducer sheath 80, e.g., based upon theincreased weight and/or resistance to proximal movement). Thepositioning member 14 may be withdrawn further until the positioningelement 46 contacts the wall of the vessel 94 and resists furtherwithdrawal, thereby providing a second tactile feedback. The introducersheath 80 may be pulled proximally by the positioning element 46 as thepositioning member 14 is withdrawn, e.g., until the distal end 84 of theintroducer sheath 80 is withdrawn from the vessel 94 into the puncture90, as shown in FIG. 5A.

Proximal tension may be applied and/or maintained on the positioningmember 14 to hold the positioning element 146 against the wall of thevessel 94, e.g., to seal the puncture 90 from the vessel 94 and/orprevent further removal of the positioning member 14. The proximaltension may be maintained manually or using a tensioner device (notshown) to provide temporary hemostasis, e.g., during the subsequentsteps. Exemplary tension devices are disclosed in co-pending applicationSer. No. 10/806,952, filed Mar. 22, 2004, the entire disclosure of whichis expressly incorporated herein by reference.

Turning to FIGS. 3B and 5B, the cartridge 16 (carrying the sealant 2)may be advanced distally over the positioning member 14 into thepuncture 90. For example, FIGS. 3A and 3B show the cartridge 16,carrying the sleeve 50 over the distal end 24 of the tubular member 20,being advanced distally over the positioning member 14 towards theintroducer sheath 80. As the cartridge 16 is advanced, the sleeve 50 maycontact the introducer sheath 80, which may prevent further advancementof the sleeve 50. For example, the distal portion 54 of the sleeve 50may at least partially enter the hub 83 of the introducer sheath 80 andthe proximal portion 52 of the sleeve 50 may abut the hub 83, as shownin FIGS. 5B and 5C, thereby preventing further advancement of the sleeve50. If the sleeve 50 is releasably attached to the tubular member 20,advancement of the cartridge 16 to this point may release the sleeve 50from the tubular 20.

The cartridge 16 may be further advanced into the introducer sheath 80toward the positioning element 46, whereupon the sleeve 50 may remainsubstantially stationary relative to the introducer sheath 80 and,consequently, slide proximally over the tubular member 20. Thus, thedistal end 24 of the tubular member 20 may exit the distal portion 54 ofthe sleeve 50 and enter the introducer sheath lumen 86. Optionally, thedistal portion 54 of the sleeve 50 may have sufficient length to atleast partially open the valve(s) within the introducer sheath hub 83,e.g., to facilitate the distal end 24 of the tubular member 20 beingadvanced into the introducer sheath lumen 86. Thus, the sleeve 50 mayprotect the slitted distal tip 25 of the tubular member 20 until thedistal tip 25 passes into the hub 83 and/or lumen 86 of the introducersheath 80.

The cartridge 16 may be advanced until a component of the cartridge 16encounters a stop on the positioning member 14, thereby preventingfurther advancement of the cartridge 16 and/or spacing the sealant 2 apredetermined distance from the positioning element 46, e.g., about zeroto five millimeters (0-5 mm) from the positioning element 46 or zero totwo millimeters (0-2 mm) into or beyond the positioning member 14. Forexample, as shown in FIG. 4B, the cartridge 16 may be advanced until thedetent 41 a on the positioning member 14 enters the recess 23 b in thecartridge hub 23. Alternatively, if the cooperating features 31, 23 bare omitted, the cartridge 16 may be advanced into the introducer sheath80 until the distal end 24 contacts the expanded positioning element 46(not shown), which may provide tactile feedback that the cartridge 16has been advanced sufficiently, or the sealant 2 is otherwise positionedwithin the puncture 90.

Thereafter, as shown in FIG. 5D, the tubular member 20 of the cartridge16 may be retracted, e.g., by pulling proximally on the hub 83 of theintroducer sheath 80, to withdrawn the introducer sheath 80 and tubularmember 20 from the puncture 90 and expose the sealant 2 within thepuncture beyond the introducer sheath distal end 84. Optionally, thesleeve 50 may include one or more locking elements (not shown) that maycouple the introducer sheath 80 to the sleeve 50, similar to theembodiments disclosed in application Ser. No. 11/864,835, filed Sep. 28,2007, and published as U.S. Publication No. 2009/0088793, the entiredisclosure of which is expressly incorporated by reference herein. Thus,in this alternative, if the user pulls proximally on the sleeve 50rather than the introducer sheath 80, the introducer sheath 80 andtubular member 20 may still be withdrawn together from the puncture 90.

As the tubular member 20 is retracted, the advancer member 30 mayprevent substantial proximal movement of the sealant 2, thereby exposingthe sealant 2 within the puncture 90, as shown in FIG. 5D. For example,as described above, as the cartridge 16 is advanced, the feature(s) 37on the proximal end 32 of the advancer member 30 may pass over thereduced region or first detent 41 a of the positioning member 14, asshown in FIG. 4B, thereby preventing subsequent proximal withdrawal ofthe advancer member 30 relative to the positioning member 14. Thus, whenthe cartridge 16 is then retracted, the element 37 on the advancermember 30 may abut the blunt distal edge of the reduced region or firstdetent 41 a, thereby preventing substantial proximal movement of theadvancer member 30, and the sealant 2 adjacent the distal end 34 of theadvancer member 30.

When the sealant 2 is exposed within the puncture 90, the sealant 2 maybe exposed to blood and/or other body fluids within the puncture 90.This exposure may cause the sealant 2 to absorb fluid and/or otherwiseexpand within the puncture 90, e.g., to provide hemostasis. If desired,once the sealant 2 is exposed within the puncture 90, the advancermember 30 may be advanced to compress or tamp the sealant 2, e.g.,against the positioning element 46. Optionally, the advancer member 30may include one or more markers 31, e.g., on or adjacent the proximalend 32, and the advancer member 30 may be advanced into the puncture 90a desired distance, which may be confirmed by monitoring the markers 33.In addition or alternatively, as shown in FIG. 4B, the positioningmember 14 may include a second detent 41 b over which the advancermember 30 may pass when advanced a predetermined distance. The seconddetent 41 b may provide an audible confirmation that the advancer member30 has been advanced the predetermined distance (in addition or insteadof the visible confirmation provided by the markers 33). In addition,the second detent 41 b may ensure that the advancer member 30 is notsubsequently withdrawn once advanced the predetermined distance.

Once the sealant 2 has been exposed for sufficient time and/or tamped bythe advancer member 30, the positioning element 46 may be collapsed, andthe positioning member 14 withdrawn from the vessel 94 and puncture 90,e.g., pulling the collapsed positioning element 46 through the sealant 2and advancer member 30. The advancer member 30 may be maintainedsubstantially stationary during withdrawal of the positioning member 14,e.g., to prevent migration and/or dislodgment of the sealant 2 withinthe puncture 90. Once the positioning member 14 is completely removed,the advancer member 30 may be removed from the puncture 90, leaving thesealant 2 within the puncture 90.

Optionally, after removing the positioning member 14, liquid hydrogel orother sealing compound, or other material may be delivered into thepuncture 90, e.g., above and/or around the sealant 2, to assist inachieving hemostasis. For example, such material may be delivered viathe lumen 36 of the advancer member 30 and/or by introducing anotherdelivery device (not shown) into the puncture 90, e.g., after removingthe advancer member 30.

While the invention is susceptible to various modifications, andalternative forms, specific examples thereof have been shown in thedrawings and are herein described in detail. It should be understood,however, that the invention is not to be limited to the particular formsor methods disclosed, but to the contrary, the invention is to cover allmodifications, equivalents and alternatives falling within the scope ofthe appended claims.

1-24. (canceled)
 25. A method for sealing a puncture extending throughtissue to a body lumen, the puncture having an introducer sheaththerein, comprising: providing an elongate positioning member includingproximal and distal ends, a cartridge slidable on the positioning memberand carrying a sealant and an advancer member therein, and a slidablesleeve located over a distal end of the cartridge; advancing the distalend of the positioning member through a lumen of the introducer sheathuntil a positioning element thereon is disposed within the body lumen;advancing the cartridge over the positioning member until the sleeve onthe cartridge contacts a proximal end of the introducer sheath; furtheradvancing the cartridge to a distal position such that the cartridgedistal end enters the introducer sheath lumen while the sleeve isstopped by the introducer sheath, the sleeve sliding over the cartridgeto expose the cartridge distal end within the introducer sheath lumen;and retracting the introducer sheath and cartridge at least partiallyfrom the puncture, thereby exposing the sealant within the puncturedistally beyond the introducer sheath.
 26. The method of claim 25,further comprising, before advancing the cartridge over the positioningmember: expanding the positioning element within the body lumen; andretracting the positioning member until the expanded positioning elementcontacts a wall of the body lumen.
 27. The method of claim 25, furthercomprising: collapsing the positioning element after retracting theintroducer sheath and cartridge to expose the sealant within thepuncture; and withdrawing the positioning member from the puncturethrough the sealant and advancer member.
 28. The method of claim 27,wherein the advancer member is held substantially stationary while thepositioning member is withdrawn from the puncture to prevent substantialproximal movement of the sealant.
 29. The method of claim 25, furthercomprising advancing the advancer member to compress the sealant withinthe puncture.
 30. The method of claim 25, wherein the sleeve comprises adistal portion that enters a hub of the introducer sheath when thecartridge distal end is advanced into the introducer sheath lumen. 31.The method of claim 30, wherein the introducer hub comprises ahemostatic valve, and wherein the sleeve distal portion at leastpartially opens the valve to accommodate the cartridge distal end beingadvanced into the introducer sheath lumen.
 32. The method of claim 25,wherein the cartridge is advanced until the cartridge encounters a stopon the positioning member, thereby preventing further advancement of thecartridge and locating the sealant a predetermined distance from thepositioning element.
 33. The method of claim 25, wherein, when thecartridge is advanced to the distal position, cooperating elements onthe advancer member and the positioning member prevent subsequentproximal movement of the advancer member relative to the positioningmember when the introducer sheath and cartridge are retracted.
 34. Themethod of claim 33, wherein after retracting the introducer sheath andcartridge to expose the sealant, advancing the advancer member tocompress the sealant until the advancer member passes over anotherelement on the positioning member that prevents subsequent proximalmovement of the advancer member relative to the positioning member.